Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer

SCRI Development Innovations

Status and phase: Completed; Phase 2; Phase 1

Conditions: Esophagus Cancer

Treatments: Drug: Oxaliplatin; Radiation: Radiation therapy; Drug: Docetaxel; Drug: Capecitabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193128

SCRI GI 57

Details and patient eligibility

About

In this phase I/II trial, we will evaluate a novel combination of chemotherapy, used concurrently with radiation therapy, in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction. In the brief phase I portion of this trial, we will determine whether 2 drugs (docetaxel/oxaliplatin) or 3 drugs (docetaxel/oxaliplatin/capecitabine) can be used concurrently with radiation therapy. If the 3-drug regimen is tolerated, the phase II portion will proceed with this regimen. If the 3-drug combination is considered too toxic, the phase II study will proceed with docetaxel/oxaliplatin in combination with radiation therapy.

Full description

Upon determination of eligibility, patients will be receive:

Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy

If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria:

• Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.
• Must be surgical candidates
• No previous treatment for esophageal cancer
• Must have measurable or evaluable disease
• Able to perform activities of daily living with minimal to no assistance
• Adequate bone marrow, liver and kidney function
• Provide written informed consent

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

• Tumor location in the proximal esophagus
• Metastatic disease or locally advanced cancer
• Moderate to severe peripheral neuropathy
• Serious pre-existing medical illnesses
• Significant heart disease
• Treated for an invasive cancer within the previous 5 years
• Women who are pregnant or breast-feeding
• Age < 18 years

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.

Treatment:

Drug: Docetaxel

Radiation: Radiation therapy

Drug: Oxaliplatin

Cohort 2

Experimental group

Description:

Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions). Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.

Treatment:

Drug: Capecitabine

Drug: Docetaxel

Radiation: Radiation therapy

Drug: Oxaliplatin